Type 1 Diabetics get good news
As I have written before, Type 1 diabetes (T1D) is a horrific disease. It is a leading cause of stroke, heart disease, blindness, kidney disease and non-traumatic amputations. It also costs a lot to manage. The media has been full of stories of unfortunate people who have had to choose between taking insulin or food. The Inflation Reduction Act, passed in August, caps the cost of a vial of insulin at $35 for Medicare beneficiaries, but does nothing for diabetics not on Medicare. About 70% of the nation’s 1.9 million Type 1 diabetics are on Medicare.
Research has proven Type 1 diabetics contract the disease in three stages over time. According to a 2015 study on the presymptomatic stages of Type 1 diabetes:
Insights from prospective, longitudinal studies of individuals at risk for developing type 1 diabetes have demonstrated that the disease is a continuum that progresses sequentially at variable but predictable rates through distinct identifiable stages prior to the onset of symptoms. Stage 1 is defined as the presence of β-cell autoimmunity as evidenced by the presence of two or more islet autoantibodies with normoglycemia and is presymptomatic, stage 2 as the presence of β-cell autoimmunity with dysglycemia and is presymptomatic, and stage 3 as onset of symptomatic disease.
Type 1 diabetics go through two stages of disease development before full-blown diabetes appears in Stage 3. Imagine a platform diver. Stage 1 is climbing to the platform and standing at the edge. Stage 2 is lifting off and moving through the air. Stage 3 is hitting the water and getting very wet. Diabetics don’t know they have the disease until they hit the water. But what if they did, and what if the time in the air between the platform to the water could be extended, say by 25 months?
On 17 November, the FDA approved a biologic therapy that delays the onset of Stage 3 by about that much.
The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield, from ProventionBio and Sanofi is given daily through intravenous infusion over two weeks. And it works. Patients who take it extend Stage 2 by a little more than two years.
But there’s a catch, two, in fact. First, PreventionBio announced last week it is pricing Tzield at $193,900, which is considerably higher than insurers anticipated. Second, how does a person know they’re in Stage 2 and, therefore, should be taking the drug? The answer is screening for autoantibodes that are markers for diabetes. This will also incur a cost. More about that below.
The question to be answered is will insurers cover the considerable cost for screening and drug infusion?
In 2014, the FDA approved Harvoni as treatment for Hepatitis C, which is the leading cause of liver failure. Hep C is a life-threatening disease. Harvoni cured it. Completely. Its maker, Gilead, priced the pill at $95,000 for a twelve-week course of treatment. At the time, I was a Director at a Boston HMO. We wrestled with the cost issue. In the end, because Harvoni cured what was a horrific and terrifically costly disease, we gladly decided to provide it for our members.
Tzieild is different. It does not cure diabetes. Rather, it delays its onset. The American Diabetes Association and the Juvenile Diabetes Research Foundation (JDRF) are ecstatic about the arrival of Tzield. They point out this is the first time a successful treatment for diabetes has appeared on the scene, although it’s not really a treatment. However, they’re concerned about the screening issue.
Aaron Kowalski, CEO of JDRF, says the main challenge in prescribing Tzield will be finding people who need it. The drug is approved for people who don’t have any symptoms of the disease and may not know they’re on the road to getting it.
“Screening becomes a really big issue, because what we know is, about 85% of type 1 diagnoses today are in families that don’t have a known family history,” Kowalski said. “Our goal is to do general population screening” with blood tests to look for markers of the disease.
It will be interesting to learn how insurers and health plans react to Tzield. According to the JDRF, 64,000 people a year are diagnosed with Type 1 diabetes. If every one of them received the drug the total cost would be about $12.5 billion. But if you were one of the 64,000, my guess is you’d happily stand in line for it. So would I.
Donald Trump and the Mar-A-Lago fiasco
By now, every sentient person in America knows ex-president Donald Trump dined last week with Nick Fuentes, the poster child for anti-Semitic white nationalism, and Kanye West, who now calls himself Ye and has also spouted anti-Semitic whinge. Afterwards, when social media lit up like the Rockefeller Center Christmas tree, Trump claimed he didn’t know Fuentes was going to be there; West just brought him along.
Putting aside the fact that Trump’s Secret Service detail would never in a month of Sundays allow just anyone to drop in to break bread with the big cheese without getting clearance from the big cheese himself, I’m more concerned with the response of the Republican Party’s leadership to this. Republicans who are likely to run for President, notably Mike Pence and Chris Christie, criticized their former leader, although it took them two or three days to do it. It took more than a week for anyone in Republican leadership to put their wet finger in the air and decide to say he shouldn’t have done it.
The stench wafting from the halls of Congress is remarkable, indeed.
A personal note
Starting tomorrow I shall be away from this, and any other, keyboard for a little bit.
Since I was eight years old, I have been an avid, competitive, pretty good, tennis player. I’ve calculated that in the intervening years I have hit somewhere around just under a million overhead smashes. That’s a lot of serves and put-aways. And they have taken their toll. So, at 7:00 AM tomorrow morning, a very good doctor (I hope) will be concentrating deeply (I hope) on the job of giving me a new shoulder. I’m told it will be a little painful for a while, but on the other side lies bliss, and more overheads.
I look forward to being back at the keyboard.
